Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence

NCT06658704 | Active Not Recruiting

• 1 other identifier: Dnr 2024-03415
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore effectiveness on physical activity, function and psychometrics in relation to an exercise intervention in physically inactive middle-aged men and women. The main questions it aims to answer are:

• Is the exercise intervention effective in increasing physical activity, function and motivation towards exercise? Is there an intervention effect in physical activity, function and psychometrics at 6-, 12- and 24 months post baseline?
• Can barriers and facilitators towards increased physical activity be identified in the two groups of the study? All participants will first receive standard care for physically inactive patients, i.e. Physical activity on Prescription (PaP), followed by allocation to an exercise intervention (EI) group or a control group. The EI group will be offered an additional exercise intervention for 16 weeks consisting of 1-2 training sessions per week of a combination of aerobic and resistance training at a private fitness centre. The control group will be asked to adhere to their PaP. Researchers will assess physical activity, function and psychometrics in the two groups at 6-, 12- and 24 months to evaluate the intervention effect. Additionally, interviews with the participants in the control and EI groups will be performed in order to explore barriers and facilitators towards increased physical activity in formerly inactive patients.

Conditions

Physical Inactivity

Keywords

Physical Inactivity; Exercise Referral Scheme; Physical activity on Prescription; Exercise intervention

Outcome Measures

Primary Outcomes (1)

• Self-reported exercise and physical activity

  One question regarding exercise and one question regarding every day physical activity in a typical week. The question regarding exercise comprises 6 answer alternatives ranging from 0 min to more than 120 min per week. The question regarding every day physical activity comprises 7 answer alternatives raging from 0 min to more than 300 min per week. The questions are produced by the Swedish National Board of Health and Welfare.

  Baseline, 6-, 12- and 24 months

Secondary Outcomes (9)

• Device measured physical activity level

  Baseline, 6-, 12- and 24 months

• Daily step count

  Baseline, 6-, 12- and 24 months

• Cardio-respiratory capacity

  Baseline, 6-, 12- and 24 months

• Upper limb strength

  Baseline, 6-, 12- and 24 months

• Lower limb muscle strength

  Baseline, 6-, 12- and 24 months

Other Outcomes (1)

• Exploring barriers and facilitators towards physical activity

  12- and/or 24 months

Study Arms (2)

Exercise intervention

EXPERIMENTAL

Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. Participants are invited to a 16 week exercise intervention at a private fitness center after they have received their PaP. The exercise, including a variety of aerobic and resistance training, is performed in a group setting starting with one session per week for the first two weeks and then two sessions per week for week 3-16. Follow-up tests is also included after 6-, 12- and 24 months.

Behavioral: Supervised exercise in a group setting; Behavioral: Usual care (Physical activity on Prescription)

Control

ACTIVE COMPARATOR

Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. Follow-up tests is also included after 6-, 12- and 24 months.

Behavioral: Usual care (Physical activity on Prescription)

Interventions

Supervised exercise in a group setting BEHAVIORAL

Participants are invited to a 16 week exercise intervention at a private fitness center after they have received their PaP. The exercise, including a variety of aerobic and resistance training, is performed in a group setting starting with one session per week for the first two weeks and then two sessions per week for week 3-16.

Exercise intervention

Usual care (Physical activity on Prescription) BEHAVIORAL

Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks.

Control; Exercise intervention

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physically inactive persons as defined as not meeting the current recommendations of at least 150 minutes of moderate to vigorous physical activity per week. This criterion is self-assessed by potential participants.
• Age 40-60 years

You may not qualify if:

• Physical disability that affects the ability to perform the exercise intervention.
• Heart failure or severe degenerative disease, e.g. malignant cancer, multiple sclerosis etc.
• Myocardial infarction or stroke during the last 12 months.
• Heart conditions including angina pectoris that is worsened with exercise.
• Neuromuscular, musculoskeletal, or rheumatic conditions that is worsened with exercise.
• Hypertension grade III, i.e. systolic blood pressure above 180 mmHg and/or diastolic blood pressure over 110 mmHg.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå University

Umeå, Västerbotten County, SE-90187, Sweden

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Andreas Hult, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A two arm intervention study with allocation to usual care (Physical activity on Prescription) or usual care (Physical activity on Prescription) + an exercise intervention.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 26, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)